Volume 19, Number 4—April 2013
Letter
Hepatitis E Virus and Porcine-derived Heparin
C. Crossan, L. Scobie, J. Godwin, J.G. Hunter, T. Hawkes, and H.R. Dalton
Table
Heparin samples tested for hepatitis E virus, porcine circovirus 2, and porcine parvovirus*
| Producer, proprietary name/other names, batch or lot no. | Use | Excipient | Concentration | Quantity tested, IU | 95% upper CL, IU−1† |
|---|---|---|---|---|---|
| Sanofi‡ | |||||
| Clexhane/enoxaparin | Injection | H2O | |||
| ILA01 | 20 mg/0.2 mL | 6,000 | 0.0006 | ||
| 34751 | 40 mg/0.4 mL | 4,000 | 0.0009 | ||
| OLC56 | 80 mg/0.8 mL | 8,000 | 0.0005 | ||
| ILA53 | 60 mg/0.6 mL | 6,000 | 0.0006 | ||
| OLC07 | 100 mg/ mL | 10,000 | 0.0004 | ||
| 12255 |
120 mg/0.8 mL |
12,000 |
0.0003 |
||
| Pfizer§ | |||||
| Fragmin/dalteparin sodium | Injection | H2O pH adjusted with HCl or NaOH | |||
| 12339A01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
| 12338A01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
| 12327B01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
| 12257A01 | 5,000 IU/0.2 mL | 15,000 | 0.0002 | ||
| 12444A01 | 5,000 IU/0.2 mL | 10,000 | 0.0004 | ||
| 12122C01 | 7,500 IU/0.3 mL | 7,500 | 0.0005 | ||
| 74774D51 | 10,000 IU/0.4 mL | 10,000 | 0.0004 | ||
| 74871B51 | 12,500 IU/0.5 mL | 25,000 | 0.0001 | ||
| 74779G51 | 12,500 IU/0.5 mL | 12,500 | 0.0003 | ||
| 74871B51 | 12,500 IU/0.5 mL | 12,500 | 0.0003 | ||
| 74743C52 | 15,000 IU/0.6 mL | 30,000 | 0.0001 | ||
| 74755A51 | 15,000 IU/0.6 mL | 30,000 | 0.0001 | ||
| 74832A52 | 15,000 IU/0.6 mL | 15,000 | 0.0002 | ||
| 74832A01 | 15,000 IU/0.6 mL | 15,000 | 0.0002 | ||
| X08580 |
¶ |
¶ |
100,000 IU/4 mL |
100,000 |
0.00004 |
| Wockhart# | |||||
| Monoparin | Injection | H2O pH adjusted with HCl or NaOH | |||
| PK40319 | 1,000 IU/mL | 20,000 | 0.0002 | ||
| 3090 | 1,000 IU/mL | 10,000 | 0.0004 | ||
| Hepsal | Flushing | NaCl, H2O, HCl, and NaOH | |||
| 5000090 | 10 IU/mL | 120 | 0.03 | ||
| 91180 | 50 IU/mL | 50 | 0.07 | ||
| 1069 |
200 IU/mL |
200 |
0.02 |
||
| Leo** | |||||
| Heparin sodium | Intravenous flushing | Benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium citrate, NaCl, and H2O | |||
| DD7314 | 100 IU/mL | 200 | 0.02 | ||
| CC4338 |
100 IU/mL |
200 |
0.02 |
||
| Celgene††, | |||||
| Refludan/Lepirudin, 25561611A‡‡ |
Powder used for solution for injection/infusion |
Mannitol, NaOH, and H2O |
12.5 mg/mL |
NA |
NA |
| Total quantity tested | NA | NA | NA | 404,270 | 0.000009 |
*NA, not applicable.
†The 95% upper confidence limit of the probability of a virus-positive result per IU was calculated on the basis of the quantity tested for each batch. This was estimated, assuming perfect detection of a Poisson process, by using Fisher exact test. For the pooled result, the upper 95% estimate is ≈1 per 100,000 IU.
‡Sanofi (Guilford, UK).
§Pfizer (Sandwich, UK).
¶Multidose vials used for injection, Excipients: Benzyl alcohol and H2O.
#Wockhart (Wrexham, UK).
**Leo (Buckinghamshire, UK).
††Celgene (Uxbridge, UK).
‡‡Non-porcine–derived anticoagulant alternative.
Page created: March 13, 2013
Page updated: March 13, 2013
Page reviewed: March 13, 2013
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.